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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM HIP OTHER IMPLANT

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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX25MM HIP OTHER IMPLANT Back to Search Results
Catalog Number 121725500
Device Problem Component Missing
Event Date 09/25/2017
Event Type  Malfunction  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported that upon the shrink wrap opened, it was noticed the product box was empty. There was no product inside.

 
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

Investigation summary: the information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. Device history lot: null. Device history batch: null. Device history review: null. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.

 
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Brand NamePINN CAN BONE SCREW 6.5MMX25MM
Type of DeviceHIP OTHER IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
suzhou industrial park
warsaw IN 46581 0988
Manufacturer (Section G)
JJMSZ PLANT FOR STK. & N-STK.
no. 299, changyang street
suzhou industrial park
suzhou, jiangsu 21512 -6
CH  21512-6
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581-0988
5743725905
MDR Report Key7002127
Report Number1818910-2017-28106
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121725500
Device LOT NumberD16011527
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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